A federal court in Delaware has rejected a challenge by Ranbaxy Laboratories on two patents for Pfizer's blockbuster cholesterol-fighting drug Lipitor (atorvastatin), protecting the drug's exclusivity until June 2011, Pfizer said today.
Judge Joseph Farnan of the United States District Court for the District of Delaware ruled Pfizer would be entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for marketing its generic version of atorvastatin until 2011. The injunction against Ranbaxy will remain in place during the appeals process.
The decision marks Pfizer's second major victory over Ranbaxy, which is using legal challenges in an attempt to overturn Pfizer's atorvastatin patents in the U.S. and other markets. On October 12, the U.K.'s High Court of Justice upheld the exclusivity of the basic patent covering atorvastatin, which will prohibit Ranbaxy from introducing a generic version of Lipitor in the U.K. until the patent expires in November 2011. The British court ruled that the calcium salt patent, which expires in the U.K. in 2010, was invalid. Pfizer said it would appeal this decision, which has no bearing on rulings in other jurisdictions.
Pfizer CEO Hank McKinnell said today in a statement: "Together with the decision in October by the United Kingdom's High Court of Justice, we have now successfully defended our Lipitor patent rights in two important jurisdictions. We will continue to defend against any and all patent challenges that seek to undermine our mission of finding new therapeutic innovations for the patients we serve."
However Ranbaxy said it would begin an appeals process immediately.
"We are committed to bringing lower-cost, reliable medicines to health-care systems worldwide," Ranbaxy president Malvinder Singh said in a statement.